Institutional Review Board (IRB) Application

Institutional Review Board (IRB) Application

Instructions for Electronic Submission

Process for Students

1) The student or postdoctoral fellow sends an e-mail to his/her faculty supervisor/mentor with all of the required IRB documents attached.

2) If the faculty supervisor approves the application, she or he then forwards the e-mail to this effect with all of the documents to the department chair. For example, the approval might read, “I have reviewed the attached IRB documents and approve this application.” If your mentor fails to approve the application, we will return it to the student or postdoctoral fellow to make the necessary revisions. If an administrator serves as the student’s mentor for the research, the administrator/supervisor will send the e-mail concerning her or his approval to the chair of the department that houses the student’s program.

3) If the department chair approves the application, she or he then forwards the e-mail with all documents attached and a statement of approval to the college dean (or dean’s designate). If the dean fails to approve the application, it is returned to the student or postdoctoral fellow to make the necessary revisions.

4) The dean forwards the e-mail and all attachments with a statement of approval andthe running history of approvals to Marie Nitopi, Ed.D., IRB Coordinator, at .

Process for Faculty

1) The faculty member sends an e-mail with all required IRB documents attached to the dean (or dean’s designate).

2) The dean forwards the e-mail with all IRB documents attachedand a statement of approval and the running history of approvals to Marie Nitopi, Ed.D., IRB Coordinator, at .

Process for Administrators

1) The administrator sends an e-mail with all required IRB documents attached to his or her unit supervisor.

2) The unit supervisor forwards the e-mail with a statement of approval andthe running history of approvals to Marie Nitopi, Ed.D., IRB Coordinator, at .

NOTE:Only St. John’s e-mail accounts may be used as this is your electronic signature.

Principal investigators from outside institutions must use their institution’s e-mail accounts.

If you have any questions concerning the IRB process, contact Marie Nitopi, Ed.D., IRB Coordinator, at or 718-990-1440.

Protocol

Request for Approval of Human Participants Research Application Form

OHRP Federal Wide Assurance #FWA 00009066

NB: Type all parts of the application, rename it appropriately,save it as a digital document,and submit the Word file.

Principal Investigator:

E-mail Address (required):

Phone: Department:

Project Title:

Coinvestigators:

For Student and Postdoctoral Fellows Research only:

Name of Faculty/Administrator/Mentor:

Department: Phone:

*** ALL APPLICATIONS REQUIRE A DEAN’S APPROVAL.***

Principal Investigators:By e-mailing this form and all supplemental materials, you attest to the following:

“I certify that all information contained in this application is accurate, that no other procedures affecting human participants will be employed in this research, and any modifications in this project that could have the potential to affect participants will be submitted for approval by St. John’s University’s Institutional Review Board (IRB) prior to use.”

For MENTORS of Student and Postdoctoral Research only:

Faculty Supervisors: By forwarding this form and the supplemental materials via e-mail, you state the following:“I certify that I will directly supervise this research and will assure that all provisions of approval will be faithfully employed by the investigator.”

Academic/Administrative Review:

All STUDENT and POSTDOCTORAL FELLOW projects submitted to the St. John’s University IRB must be approved by thestudent’s or the fellow’s faculty mentor, the respective department chair, the dean of the student’s college, or administrative unit supervisor.

Site(s) of Research:

Site Supervisor: Phone:

Length of Study: Starting Date: Length of Participant Involvement:

Funding Source: St. John’s Fed./State/City Gov’t. Agency:

Other: None

NB: St. John’s University’s IRB approval of research projects is valid for ONE YEAR ONLY. Approval of the continuation of research is possible on a yearly basis. After one year has expired, the researcher must apply for an extension or submit anew proposal.

Completed applications must be received by the 15th of the month prior to committee review. All applications received after that date will be reviewed in the following monthly cycle. Applications will be considered in the order in which they are received.

Please answer all questions on this form to the best of your ability. Most rejections or delays in approval of IRB protocols result from the applicant’s failure to provide clear and complete answers to each question. Poor descriptions of identification of participants, consent process, and level of risk account for most of the delays.

THE BOARD WILL NOT REVIEW ANY DESCRIPTION OF THE PROTOCOL EXCEPT THE ONE YOU PROVIDE ON THIS FORM. Do not attach any dissertation, theses, or grant proposals or sections of proposals. The IRB will return, without review, any application that does not follow the instructions. You could, of course, copy and paste text from a proposal if it answers the appropriate question on this form.

The spaces on this form will expand automatically to accommodate your responses.

The IRB will return this application without review if you fail to provide copies of the instruments and surveys you will use, informed consent and assent forms, and your and your mentor’s proof of certification to interact with human subjects.

1. Please indicate the category that best describes the present protocol:

Faculty-supervised undergraduate student-initiated research

Faculty-supervised graduate student-initiated research

Master’s thesis

Doctoral dissertation

Faculty-supervised postdoctoral fellow research

Faculty or administrator research

Other (please describe):

2. Is this human subject research?

Investigators conducting human subject research must satisfy Department of Health and Human Services (DHHS) regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subject research, as applicable. When considering whether an activity meets the definition of human subject research perDHHSregulations,one must consider two federal definitions:researchandhuman subject.

Researchis asystematic investigation including research development, testing, and evaluation, designed todevelop or contribute to generalizable knowledge.

Pilot studies are research, and you are to submit IRB applications for them.

Ahuman subjectis defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes asubject's opinion on a given topic.

“Systematic investigation" is an activity that involves a prospective plan that incorporates collection of either quantitative or qualitative data, and the analysis of the data answer a question.

If this study will be used solely for the purpose of program evaluation in your class, course, program, department, college, or the University, it is not research.

Is this study Human Subject Research? YesNo

Do you plan to disseminate the results of this research through professional/scientific conference presentations or publications to expand academic knowledge? Yes No

Examples of activities that typically are not generalizable include:

biographies
oral histories that are designed solely to create a record of specific historical events
service or course evaluations, unless they can be generalized to other individuals
services, courses, or concepts where it is not the intention to share the results beyond the SJU community
classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
quality assuranceactivities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the SJU community.

3.METHOD:

A.Provide a brief description of the purpose of the proposed research in nontechnical language that could be understood by an educated person who is not a scholar in your field.

B. Summarize below the procedures you will use with the subjects. Please include all research procedures, e.g., how the psychological or physiological intervention will be conducted, anticipated participants’ behaviors, the investigator's behavior during procedure, how you will collect the data, how psychological or physiological intervention will be conducted, how long the procedures will take the subjects to complete, etc.

C. Existing Data files

If you are only using existing data files or a publically available data file, you should complete the Exempt application. Please download that form at

stjohns.edu/about/administrative-offices/provost/grants-and-sponsored-research/human-participants-irb-animal-use-research.

D. Indicate the method of data collection you will use.(Check all applicable.)

Reviewing files or records Observations Test Treatment

Interview Questionnaire/Survey Task

Other: Explain

E.Please indicate which type of design best describes your study. (Check all applicable.)

a) Qualitative research methodsYes

b) A correlational designYes

c) An open trial design Yes

d)Anexperimental design Yes

F. If you are using a quasi-experimental or an experimental design, please describe the treatments/conditions you will use as your independent variables.Are these well-established treatments or experimental tasks, or are they new to this study?

4. SUBJECTS/PARTICIPANTS:

A. Describe the subjects you propose to recruit for your study (e.g., secondary school teachers; SJU undergraduates; elderly residents of a nursing home; fourth-grade math students, etc.):

B. Participant Demographics:

Age range:

Gender:

Total number: (include control groups)

Will you be using subjects who are part of a protected class?

Fetuses, pregnant women, or human ova invitro fertilization: Yes

Students: Yes

Children: Yes

Incarcerated individuals in pretrial facilities: Yes

Prisoner or jail inmates: Yes

Individuals on probation or parole: Yes

Mentally ill or persons whose decisionmaking capacity could be impaired: Yes

Other persons or groups who might feel coerced to participate or believe that they will be harmed if they chose not to participate: Yes

C. Describe any unique or special characteristics of your proposed subject sample:

5. RECRUITMENT:

A.How will you recruit and select subjects for participation? Explain in detailthe steps you will take in recruitment such as random sample, recruit students in certain classes, institutionalized population, ask for clinical samples, internet recruitment through social media, etc.

B.When you are recruiting subjects, you are required to show a written letter on the institution’s letterhead that you have the permission from that institution/agencies from which you are recruiting these subjects. These include subjects who are:

1) Patients or relatives of patients from a health care agency, facility, hospital, or institution

2) Incarcerated individuals, inmates, probationers, paroleesfrom a correctional facility or organization, or relatives of such individuals

3) Students or relatives of students from an elementary, middle, or high school, or college or university.

4) Employees of identified companies, agencies, schools, nonprofits, or governmental organizations.

The IRB conditionally approves a study pending written permission from the institution. You can obtain a sample letter by visitingstjohns.edu/about/administrative-offices/provost/grants-and-sponsored-research/human-participants-irb-animal-use-research.

Scroll to “IRB Guidelines and Policies” and click on “Guidelines for Institutional Approval.”

If you indicated that you are recruiting subjects from any of the above groups,please specify whether you have the appropriate letter of agreement or if the letter of agreement is pending.

YesLetter of agreement is pending

If you are conducting an e-mail solicitation of college students in a class, you do not need such approval, as you will be allowing the course instructor to use his/her judgment as to whether to disseminate the request.

C.You must submit copies of all recruitment materials (flyers, advertisements, scripts, etc.). Please attach such documents in separate files that you will include with your IRB application.

6.INFORMED CONSENT:

A.Your consent form must include eight basic elements. This comes from the Code of Federal Regulations Title 21, Section 50.25

The Eight Basic Elements of Informed Consent are as follows:

Statement explaining the purpose of the research, the procedures to be followed, the duration of participation, and any investigational treatments or procedures
Description of foreseeable risks and discomforts to volunteers
Description of benefits that the volunteers can reasonably expect
Disclosure of any alternative treatments or procedures that might be advantageous to the volunteers
Statement about how volunteer confidentiality will be maintained
Explanation of compensation and whether medical treatments are available if injury occurs
List of contacts to answer study-related questions and to help with research-related injuries
Statement that participation is voluntary and that there is no penalty or loss of benefits for refusing to participate.

Also, SJU requires that your consent and assent forms must appear on the St. John’s University Department letterhead with the most recent University crest.

Also, when recruiting minors, you must obtainparental permission in writing. Explain how you will also obtain verbal assent from individual child participants.

Parental permission is a necessary but not a sufficient condition of research with children. You must also ask a child personally to participate, and he or she could refuse even if his or her parent has approved.

If audio or video recordings are produced in this study, the subjects must know they are being recorded.

B. Will you be recording your subjects’ responses on audio and or video during the data collections?

YesNo

If you will make any audio or video recordings of any interviews or behaviors, you must inform the participants that you are recording them, and you must obtain additional consent from them to do so beyond their general consent to participate in the study. Note that the participants' right to confidentiality is absolute.

C. If you are sharing any audio or video recordings of the data from this study with other researchers outside of St. John’s University, or if you are depositing any audio or video recordings of the data from this study with any data library, have you:

Informed the subjects that the recordings would be shared?